Effects of Intermittent Hypoxia-Hyperoxia in Older Adults
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Device: Hypoxic Gas Mixture, Sham Hypoxic-Hyperoxic exposure.
- Кому может быть актуально
- Состояния в реестре: Sedentary Behavior, Frailty, Older Adults. Базовые параметры: 65 лет — 90 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effects of a 6-week Hypoxia-hyperoxia Exposure Protocol on Sedentary Older Adults on Heart Rate Variability, Blood Pressure, Respiratory Muscle Strength, Pulmonary Function, Inflammatory Biomarkers and Arterial Oxygen Saturation, a Randomized Double-blind Placebo-controlled Clinical Trial
Обзор
The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation. According to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, inflammatory biomarkers, blood pressure, and arterial oxygen saturation. The study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo an IHHE session, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The sham group will undergo a 5-cycle protocol with an FiO2 of 21%. Both groups will follow a 6-week protocol with three weekly sessions (Monday, Wednesday, and Friday).
Вмешательства
- Устройство Device: Hypoxic Gas Mixture
The EG (Experimental Group) will undergo a 6-week intervention protocol of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany). They will breathe air with an oxygen concentration (FiO2) ranging from 10-14% for 5 minutes, followed by 3 minutes of rest in hyperoxia (FiO2 30-40%), for a total of 6 cycles. During the hypoxic phase, oxygen saturation will be maintained between 85-92%, while during the hyperoxic phase, it will be - Другое Sham Hypoxic-Hyperoxic exposure
The Sham Group (SG) will follow a single session protocol of 5 cycles of 6 minutes per session with an FiO2 of 21% using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany). Participants will be asked to sit and breath normally in each exposure. An attendance checklist will be used to monitor compliance with the placebo intervention.
Первичные конечные точки
- Heart rate variability [Срок оценки: 24 hours before intervention and 24 hours after 6 week intervention]
Вторичные конечные точки (5)
- Blood pressure [Срок оценки: 24 hours before intervention and 24 hours after 6 week intervention]
- Arterial oxygen saturation [Срок оценки: 24 hours before intervention and 24 hours after 6 week intervention]
- Respiratory muscle strength [Срок оценки: 24 hours before intervention and 24 hours after 6 week intervention]
- Pulmonary function [Срок оценки: 24 hours before intervention and 24 hours after 6 week intervention]
- Inflammatory biomarkers [Срок оценки: 24 hours before intervention and 24 hours after 6 week intervention]
Критерии участия
Критерии включения
- Being over 65 years old.
- Having no previous experience in hypoxic training.
- Engaging in less than 150 minutes of physical activity per week.
Критерии исключения
- Having any pathology that prevents the subject from being independent in terms of walking and functionality.
- Subjects with impaired cognitive abilities.
- Subjects with pulmonary hypertension, decompensated heart or respiratory disease.
- To have or have had cancer
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06686316 · 016